Axicef Plus Tablet 500mg+125mg

Product Information

AXICEF PLUS

Presentation

Axicef Plus 250/62.5 tablet: White, oblong shaped film coated tablet; each tablet contains Cefuroxime 250 mg as Cefuroxime Axetil

USP and Clavulanic Acid 62.5 mg as diluted Potassium Clavulanate BP.

Axicef Plus 500/125 tablet: White, oval shaped film coated tablet, engraved with      logo on one side and scored on the other;

each tablet contains Cefuroxime 500 mg as Cefuroxime Axetil USP and Clavulanic Acid 125 mg as diluted Potassium Clavulanate BP.

Pharmacology

Cefuroxime is a second generation cephalosporin antibiotics, which is active against a wide range of Gram-positive and

Gram-negative susceptible organisms including many beta-lactamase producing strains.

Clavulanic Acid has a similar structure to the beta-lactam antibiotics but binds irreversibly to the beta-lactamase enzymes.

The presence of Clavulanic Acid in Axicef Plus formulations protects Cefuroxime from degradation by beta-lactamase enzymes and

effectively extends the antibacterial spectrum of Cefuroxime to include many bacteria normally resistant to Cefuroxime and other

cephalosporins.

Indications

Axicef Plus is indicated for the treatment of Acute streptococcal tonsillitis and pharyngitis, Acute bacterial sinusitis, Acute

otitis media, Acute exacerbations of chronic bronchitis, Cystitis, Pyelonephritis, Uncomplicated skin and soft tissue infections &

early lyme disease in adults and children (>3 months).

Contraindications

Patients with known allergy to cephalosporins & pseudomem- branous colitis are contraindicated.

Warning and precautions

Axicef Plus should be given with care to patients receiving concurrent treatment with potent diuretics & who have history of

colitis.

Side-effects

Candida overgrowth, Clostridium difficile overgrowth, eosinophilia, thrombocytopenia, leukopenia, haemolytic anaemia, headache,

dizziness, diarrhoea, nausea, abdominal pain, vomiting, pseudomembranous colitis, transient increases of hepatic enzyme levels,

jaundice, hepatitis, skin rashes, urticaria, pruritus, angioneurotic oedema.

Use in pregnancy & lactation

During pregnancy: There are limited data from the use of cefuroxime in pregnant women. Studies in animals have shown no harmful

effects on pregnancy, embryonal or foetal development, parturition or postnatal development. Cefuroxime axetil should be

prescribed to pregnant women only if the benefit outweighs the risk.

During lactation: Cefuroxime is excreted in human milk in small quantities. Adverse effects at therapeutic doses are not expected,

although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded. Breastfeeding might have to be

discontinued due to these effects. The possibility of sensitisation should be taken into account. Cefuroxime should only be used

during breastfeeding after benefit/risk assessment by the physician in charge.

Drug interactions

Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting

state and tend to cancel the effect of enhanced absorption after food.

Cefuroxime is excreted by glomerular filtration and tubular secretion. Concomitant use of probenecid is not recommended.

Concurrent administration of probenecid significantly increases the peak concentration, area under the serum concentration time

curve and elimination half-life of cefuroxime.

Concomitant use with oral anticoagulants may give rise to increased INR.

Overdosage

Signs and symptoms: Overdosage of Axicef Plus can cause cerebral irritation leading to convulsions.

Management Serum levels of Axicef Plus can be reduced by haemodialysis and peritoneal dialysis.

Pharmaceuticals precautions

Store below 25ºC temperature in dry place, protected from light. Keep out of children’s reach.

Packaging quantities

Axicef Plus 250/62.5 tablet: Each box contains 2×7’s film coated tablets in Alu-Alu blister in Aluminium sachet.

Axicef Plus 500/125 tablet: Each box contains 2 x 7’s film coated tablets in Alu-Alu blister in Aluminium sachet.